Efficacy and Safety of the SQ House Dust Mite SLIT-tablet in Japanese Adults and Adolescents with House Dust Mite-induced Allergic Rhinitis

Publication date: Available online 15 November 2016
Source:Journal of Allergy and Clinical Immunology
Author(s): Kimihiro Okubo, Keisuke Masuyama, Toru Imai, Kazuhiro Okamiya, Brian Sonne Stage, Dorthe Seitzberg, Akiyoshi Konno
BackgroundThe SQ HDM SLIT-tablet has been approved in 11 European countries and Japan for patients suffering from house dust mite (HDM) respiratory allergic disease.ObjectiveThis trial was conducted to confirm efficacy and safety in Japanese patients with moderate to severe HDM allergic rhinitis (AR).MethodsThe trial was a randomized, double-blind, placebo-controlled trial including 946 Japanese adults and adolescents (12-64 years). Subjects were randomly assigned to daily treatment with SQ HDM SLIT-tablet at a dose of 10,000 JAU or 20,000 JAU or with placebo (1:1:1). Primary endpoint was the total combined rhinitis score (TCRS) composed of AR symptom and medication scores, during the efficacy evaluation period. Symptom and medication scores of AR and conjunctivitis, rhinitis quality of life, and symptom-free and -severe days were evaluated as secondary endpoints.ResultsAnalysis of the primary endpoint demonstrated statistically significant reductions of the TCRS of 1.15, 22% (p<.001) in the 10,000 JAU and 0.99, 19% (p<.001) in the 20,000 JAU compared to placebo. The statistically significant treatment effect was evident from 12 weeks of treatment and onwards. All secondary endpoints, except AR medication score, were statistically significant in favor of active treatment compared to placebo. Post hoc analysis of TCRS in adolescents showed the same efficacy as adults (p<.05). The treatment was well-tolerated both adults and adolescents.ConclusionThe trial confirmed efficacy and safety profile of the SQ HDM SLIT-tablet in Japanese adult and adolescent patients with moderate to severe HDM AR. These data support the robust efficacy and safety profile of previously reported European data.

Teaser

This trial confirmed efficacy and safety of the SQ HDM SLIT-tablet in Japanese adults and adolescents with moderate to severe HDM AR. TCRS was reduced from week 12 and throughout the 1 year trial.


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